Roberta Anderson, PhD
ACE Therapeutic Strategy Head, Neuroscience
Neuroscience
SCROLL
Specialized Neuroscience CRO for Neurological and Psychiatric Clinical Trials
We navigate the complex disease mechanisms, varied symptoms and specialized endpoints involved in neuroscience clinical trials.
Allucent is a neuroscience CRO that specializes in supporting complex neuroscience clinical trials spanning a spectrum of neurological and psychiatric illnesses, each presenting unique challenges in disease evaluation and diagnosis, patient recruitment, endpoint selection and trial execution. Our A-Team has extensive therapeutic expertise in general neurology, neurodegenerative, neuromuscular diseases, rare neurological diseases, pain, sleep disorders and psychiatry. We are driving neuroscience clinical research forward, supporting biopharma sponsors through all stages of development from early research to registration and beyond, using our experience, worldwide trial capabilities and patient-centric approach. Partner with Allucent as your neuroscience CRO of choice to bring new therapies to light.
Comprehensive Neuroscience CRO Services for Neurology & Psychiatry
- Clinical development across Phases I-IV
- Protocol development, study design and dose optimization
- Global regulatory strategy and clinical development planning
- Clinical pharmacology and PK/PD expertise
- Specialized global IGNITE™ site network for study predictability
- Rater training, clinical endpoint assessment & placebo response mitigation
- Patient recruitment, engagement and retention strategies
- Expert eligibility review for screening of participants
- Tech-enabled decentralized and hybrid trial solutions
- Neuroimaging, neurophysiology and centralized image assessment
- Safety surveillance, pharmacovigilance and long-term follow-up
- Biomarker and translational research support
Depth of Neurology & Psychiatry Clinical Trial Experience
As a neuroscience CRO, Allucent has conducted a wide range of neuroscience trials, from early phase trials where dose escalation was dependent on repeated CSF sampling and neuroimaging, to worldwide Phase III trials with various interim analyses or adaptive designs.
200+
Neuroscience Studies
2896+
Global Sites
22475+
Neuroscience Patients Recruited
965+
Consulting Projects
All-time years of experience
With extensive experience across a wide range of neurology & psychiatry indications, Allucent is a specialized neuroscience CRO helping biopharma companies bring innovative therapies to light.
ADAPTIVE STUDY DESIGN
Neuroscience clinical trials need to have well-designed protocols that take into consideration complex disease mechanisms, heterogeneous patient populations and challenging clinical endpoints. As an experienced neuroscience CRO, Allucent offers medical, clinical, statistical, regulatory and therapeutic expertise to help develop evidence-based and operationally viable study designs for a wide range of neurological and psychiatric diseases. From first-in-human to pivotal trials, our experts provide help with a focus on effective patient recruitment, dose optimization, endpoint selection, and minimizing protocol complexity.
Proven success with biopharma sponsors: Hybrid SAD/MAD study design in healthy participants and participants with Alzheimer’s disease thereby avoiding two separate studies.
GLOBAL REGULATORY STRATEGY
Neuroscience clinical development often involves evolving regulatory requirements, complex benefit-risk assessment and a need to demonstrate substantial therapeutic impact in diverse and dispersed patient populations. Allucent’s experience spans worldwide regulatory strategy and engagement across clinical development, helping sponsors understand requirements across key markets and defining efficient regulatory pathways for neurological and psychiatric therapies and devices. Our neuroscience clinical research expertise helps sponsors navigate regulatory challenges and move clinical programs forward toward important development milestones.
GLOBAL SITE NETWORKS & ACTIVATION
To achieve study success, neuroscience clinical trials require access to skilled and experienced investigators and specialized sites that can manage complex assessments, procedures and patient populations. Allucent leverages our established IGNITE™ global site network to recruit qualified investigators, expedite site activation and support effective trial conduct. We have a worldwide network of sites ready to perform specialized evaluations, neuroimaging, and other complex neuroscience procedures.
Proven success with biopharma sponsors: Efficient Site Advisory Meetings to incorporate the site voice into final protocols.
PATIENT RECRUITMENT & ENGAGEMENT
Patient recruitment and retention can be challenging when it comes to neuroscience clinical research, particularly for rare neurological, neurodegenerative and psychiatric diseases, where limited patient populations, caregiver participation and extensive follow-up can be involved. Allucent creates patient-centric recruitment and engagement strategies focused on improving access, participation and retention. Our methodology has the potential to combine devoted patient engagement, caregiver support, decentralized and hybrid trial designs, and remote assessments to reduce participation burden.
TECHNOLOGY-ENABLED TRIAL CAPABILITIES
Technology can make neuroscience clinical trials more accessible, and produce richer, better-quality data. Allucent is a techology-enabled CRO that combines eCOAs, wearables, remote evaluations and decentralized or hybrid trial formats to drive patient engagement and data collection. Our preferred partner network also provides access to specialized technologies such as EEG, neuroimaging, cognitive tests and fluid biomarker testing.
Proven success with biopharma sponsors: Integrating wearable sensors and smartphone-based motor assessments to capture real-world functional changes in neurodegenerative disease research.
ENDPOINT STRATEGY & TRIAL DESIGN
For neurological and psychaitric illnesses, subjective endpoints, placebo responses and disease heterogeneity can impact clinical development, making the selection of relevant and sensitive endpoints crucial to study success. As an experienced neuroscience CRO, Allucent has specialized expertise in clinical outcomes assessments, cognitive and functional measurements, biomarkers, and other neuroscience-specific endpoints. We also support adaptive and innovative protocol design, assisting sponsors optimize research efficiency, while preserving scientific integrity and regulatory competence.
Advancing innovative therapies across neuroscience indications
Allucent’s experience as a neuroscience CRO spans general neurological, neurodegenerative, neuromuscular, psychiatric, pain, sleep disorders as well as rare neurological indications, supporting sponsors throughout every stage of clinical development. These conditions often present unique challenges, including heterogeneous patient populations, complex disease progression, subjective and variable endpoints, high placebo response, and specialized recruitment and retention requirements.
Our portfolio encompasses neurodegenerative clinical research including 13+ Alzheimer’s disease trials, as well as Parkison’s disease and ALS trials, general neurological clinical trial expertise across 21+ multiple sclerosis trials, 10+ migraine studies, and stroke and subarachnoid hemorrhage trials, pain clinical research with 34+ pain clinical trials, both chronic and acute, and psychiatric clinical trial experience across addiction, depression and anxiety/stress disorder studies: part of a broader 200+ neuroscience clinical trial portfolio.
Neuroscience Indications We Support:
General Neurology
- Epilepsies: adult and pediatric
- Multiple sclerosis (MS)
- Spinal cord injury (SCI)
- Stroke
- Subarachnoid hemorrhage
- Tourette disorder
- Traumatic brain injury (TBI)
Neurodegenerative Diseases
- Alzheimer’s disease (AD)
- Amyotrophic lateral sclerosis (ALS)
- Friedreich’s ataxia
- Huntington’s disease (HD)
- Parkinson’s disease (PD)
Neuromuscular Disorders
- Duchenne muscular dystrophy (DMD)
- Muscular dystrophy
- Myasthenia gravis (MG)
- Peripheral neuropathies
- Spinal muscular atrophy (SMA)
Pain Disorders
- Chronic pain
- Fibromyalgia
- Migraine
- Neuropathic pain
Sleep Disorders
- Idiopathic hypersomnia
- Insomnia
- Narcolepsy
- Sleep apnea
Psychiatry Disorders
- Anxiety disorders
- Depression
- Post-traumatic stress disorder (PTSD)
- Schizophrenia
- Substance use disorders
Cell & Gene Therapy for Neuroscience Clinical Trials
Allucent provides specialized expertise in cell and gene therapies to neuroscience clinical research to help develop novel therapies for neurological and neuromuscular diseases. Challenges for these programs may include targeted delivery to the central nervous system, small patient populations, new endpoints, biomarker development and long-term safety and efficacy follow-up. Allucent’s experience with neuroscience, rare diseases, pediatrics and advanced therapies helps sponsors navigate these challenges at all stages of clinical development, from early-phase studies to pivotal trials and long-term follow-up.
Rare Disease Research in Neuroscience Clinical Trials
Allucent’s rare neuroscience expertise spans complex neurological, psychiatric, neuromuscular and sleep disorders, including genetically driven conditions that frequently overlap with pediatric populations. These studies often involve small and geographically dispersed patient populations, limited natural-history data, specialized endpoints and the need for long-term follow-up. As a neuroscience CRO with experience across rare disease and pediatric development, Allucent supports sponsors with patient identification and recruitment, specialized site networks, protocol and endpoint strategy, and regulatory planning tailored to the unique challenges of rare neurological disorders.
Psychedelics for Complex Psychiatric Ailments
Allucent supports the emerging field of psychedelic clinical research, helping sponsors navigate operational, regulatory and clinical considerations that come with psychedelic therapies. Our expertise can assist studies across psychiatric conditions with a focus on specialized protocols, patient safety, complex endpoints, controlled environments for administration and appropriate assessment of treatment response including use of central raters to minimize bias and variability. Allucent combines neuroscience, clinical pharmacology, regulatory and operational expertise to help sponsors advance psychedelic programs through clinical development.
Neuroscience has reached an era of genuine disease-modifying treatments capable of preserving quality of life, despite complex challenges such as disease and patient heterogeneity. Allucent helps sponsors navigate these complexities, serving as an extension of the research community to execute meaningful trials and bring new therapies to light.
Roberta Anderson, PhD
ACE Therapeutic Strategy Head, Neuroscience
Meet Some of Our Neuroscience Experts
Partner with our neuroscience experts to advance innovative therapies with comprehensive study expertise and strategic regulatory guidance.
- Brings nearly 30 years of clinical development experience with deep specialization in neuroscience
- Broad range of indications experience across neurological disorders, including Alzheimer’s disease, stroke, sleep disorders, and Tourette’s Syndrome
- Strong regulatory expertise guiding complex submissions and approvals (FDA INDs, Health Canada CTAs, SPA), with experience across multiple phases of development
Marcus Delatte, PhD
Vice President,
Regulatory Strategy
- 12 years at FDA as Senior Toxicology/Pharmacology Reviewer
- Proven expertise in translating nonclinical data to inform clinical program design
- Expert in developing regulatory pathways, including IND and NDA applications, and expedited programs
Gilad Rosenberg, MD, MSc
Executive Medical Director, Therapeutic Medical Area Lead, Neuroscience
- 25+ years of experience managing pre-clinical, clinical, and regulatory aspects of drug development across all phases
- Pharmaceutical development expertise in a multitude of neurological indications as well as oncology and hematology
Maria Jesus Seivane
Senior Director,
Global Operations Head,
Neuroscience
- 22 years of research industry expertise managing Phase I to IV global trials across a variety of therapeutics indications including more than 15 years in Project Management
- Extensive experience with execution of complex Neuroscience trials including rare disease trials receiving market approval with EMEA, FDA and PMDA
Related Content
Additional Resources
Industry Featured Articles
Digital Technologies Transforming Neurodegenerative Trials
Learn More
White Papers
Advancing Neurodegenerative Disease Trials with Digital Health Technologies: A Regulatory Aligned Approach
Learn More
Blogs
Common Disease Mechanisms in Neurodegenerative Disorders: Insights for the Development of Disease-Modifying Therapies
Learn More
Frequently Asked Questions About Neuroscience CRO
A neuroscience CRO is a contract research organization focused on clinical trials for neurological and psychiatric conditions. Allucent Center of Expertise, Neuroscience, provides comprehensive drug development services including regulatory strategy, clinical pharmacology, protocol design, specialized neuroscience investigator site networks, patient recruitment and retention, and operational support to efficiently conduct neuroscience drug development across pre-clinical strategy to post-approval.
Allucent supports a wide range of neuroscience clinical research areas, including neurodegenerative diseases, psychiatric conditions, pain disorders, addiction disorders, Alzheimer’s disease, and seizure disorders, leveraging decades of experience and global trial execution.
Allucent applies comprehensive clinical trial feasibility to identify the optimal countries, regions, and investigator sites, drawing on its extensive neuroscience site network and tech-enabled solutions. This is complemented by tailored patient recruitment and retention strategies, leveraging decentralized and hybrid trial models and patient engagement expertise, to ensure diverse participation and sustained compliance throughout complex neurological clinical trials.
Allucent’s neuroscience CRO team offers regulatory fluency across FDA, EMA, MHRA, and other regional authorities to provide strategic guidance on evolving guidelines, biomarker use, endpoint definitions (including digital and surrogate endpoints), and streamlined regulatory pathways, helping sponsors navigate complex compliance requirements effectively.
Allucent’s Center of Expertise, Neuroscience, ensures that drug development programs are led by experts with hands-on regulatory and clinical development experience in neuroscience. Allucent combines cross-functional expertise from clinical pharmacology to biostatistics and medical affairs - with global operational capabilities, enabling sponsors to design robust neuroscience trials, manage regulatory challenges, and advance innovative CNS therapies toward approval.